FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOSKELETON® TT
DI: 00191375003151
·
Model: 4200-1113
·
TITAN SPINE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOSKELETON® TT
- Primary DI
- 00191375003151
- Version / Model
- 4200-1113
- Catalog Number
- 4200-1113
- Company Name
- TITAN SPINE, LLC
- Labeler DUNS
- 623316978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-15
- Public Version
- 4
- Public Version Date
- 2020-12-09
- Public Version Status
- Update
- Public Device Record Key
- 83b41e8b-c3ba-4b5f-92d6-14d1d75e0e35
Device Description
Shaver, 13mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAX | Intervertebral fusion device with bone graft, lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31335 | Bone curette, reusable | A manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191375003151 | GS1 |
Customer Contacts
- Phone
- +1(262)242-7801
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083714 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8.5 | Inch | |
| Height | 13 | Millimeter |